aspartame

Available for over 30 years, aspartame is approved for use in more than 100 countries around the world. Aspartame is one of the most thoroughly tested food additives in history with a comprehensive body of studies done in humans and animals. All of these studies demonstrate that aspartame is safe for human consumption.

Safety authorities have regularly reviewed new studies and they have always reconfirmed aspartame's safety. The European Food Safety Authority (EFSA) reconfirmed the safety of aspartame in 2006, 2009, 2010 and 2011.

What is aspartame and why is it used?Aspartame is a low calorie sweetener. Aspartame provides 4 calories per gram but because, weight for weight, it is approximately 200 times sweeter than sugar, very little aspartame is needed to sweeten foods. Aspartame therefore adds practically no calories to foods. Aspartame mimics well the taste of sugar, enhances citrus and other fruit flavours, and does not contribute to tooth decay.

In which products is it used?Aspartame is authorized for use as a sweetener in a wide range of foods. It is used to sweeten around 6,000 foods and beverages, including sparkling soft drinks, desserts, sweets, chewing gum, yogurt, and table-top sweeteners.

What happens to aspartame in the body once it is ingested?Aspartame breaks down in the gut into its three constituent parts: two amino acids - aspartic acid and phenylalanine - and methanol, which are then absorbed into the blood.

The two amino acids (aspartic acid and phenylalanine) are building blocks of protein and are found naturally in many everyday foods such as meat, fish, cheese, eggs and milk. Methanol is also found naturally in many foods, such as fruits and vegetables and their juices, and is part of the normal diet.

These components are used in the body in exactly the same ways as when they are derived, in much greater amounts, from common foods and beverage. For example, milk provides about 5 times more phenylalanine and 11 times more aspartic acid than a beverage sweetened with aspartame; tomato juice provides over 3 times the amount of methanol as an aspartame-sweetened beverage. Neither aspartame nor its components can accumulate in the body.

How can I tell if a product contains aspartame?People can identify foods and drinks containing aspartame by looking at the ingredients lists on product labelling. Like all food additives approved for use in the European Union, aspartame has been assigned an "E-number". Its presence in foods is indicated either by its name (i.e., "aspartame") or by its number (E-951).

Products containing aspartame should also state that it is a source of phenylalanine. This label is there to help people with a rare inherited genetic disorder called phenylketonuria (PKU). These people cannot metabolise phenylalanine from any source and need to control their intake of this amino acid.

How has aspartame's safety been tested?Aspartame was extensively tested prior to its approval. This research included four animal carcinogenicity (ability to cause cancer) studies. These studies, together with studies on genotoxicity (ability to damage the genetic material, but not necessarily causing cancer), were evaluated by regulatory bodies worldwide and it was concluded that they did not show any evidence of genotoxic or carcinogenic potential for aspartame.

The full body of science on aspartame has been reviewed by regulatory authorities around the world, including the US Food and Drug Administration (FDA) and the Joint Expert Committee on Food Additives (JECFA) of the United Nations Food & Agriculture Organisation and the World Health Organisation. In every case, aspartame was found to be safe.

Questions regarding the safety of aspartame have been raised since its approval, with discussions focusing not only on the safety of aspartame itself, but also on the safety of its breakdown products (aspartic acid, phenylalanine and methanol). Post-marketing surveillance and numerous additional animal and human studies have been conducted. All have confirmed that aspartame is safe and has no adverse health effects.

How was aspartame approved in the European Union?Aspartame was first authorised for use by individual Member States in the 1980s. European legislation harmonising the use of low calorie sweeteners in foodstuffs was introduced in 1994, following thorough safety evaluations by the European Commission Scientific Committee for Food (SCF).

Further reviews of the data on aspartame were carried out in 1988 and 2002 by the SCF. Both published and unpublished data, including all the information on genotoxicity and carcinogenicity in animals and humans, were considered. The SCF reconfirmed the safety of aspartame. Today, the European Food Safety Authority (EFSA) is responsible for the work previously carried out by the SCF.

How much aspartame can be safely consumed? What is the Acceptable Daily Intake?

The Acceptable Daily Intake (ADI) of aspartame in the European Union is 40 milligrams per kilogram of body weight. The ADI refers to the amount of aspartame that can be consumed daily in the diet, over a lifetime, without any health problems. For an adult weighing 70 kilograms, the ADI for aspartame has the sweetness equivalent of over half a kilo of sugar.

Additionally, the ADI provides a large margin of safety. Authorities determine a level of an additive that has no toxic effect in animal models, apply a safety factor of 100 (to account for the difference between animals and humans and the different sensitivities between humans), and then calculate the Acceptable Daily Intake.

Furthermore, aspartame consumption has been measured in many countries and has been found to be far lower than the ADI, even in people on weight-reduction diets, in diabetics or in children. In a recent EFSA evaluation, intake of low calorie sweeteners was assessed in a number of European countries. Intake of aspartame was less than a quarter of the ADI, even among frequent consumers.

Why did the European Food Safety Authority (EFSA) carry out its recent reviews of aspartame safety? In 2005, the European Ramazzini Foundation of Oncology and Environmental Sciences (ERF) published a study on the carcinogenicity of aspartame carried out in rats. EFSA's scientific panel found that the Ramazzini study had several flaws which brought into question the validity of the results. EFSA concluded that aspartame remains safe for human consumption and that there was no reason to revise the previously established ADI for aspartame, or to advise consumers to modify their dietary habits.

In April 2007, the ERF announced a second rat study on aspartame. This material was also reviewed by EFSA, who again concluded that there was no reason to change its opinion. In 2010, ERF published a paper based on a mouse study on aspartame. In February 2011, EFSA announced its conclusion that the validity of this study could not be assessed and its results could not be interpreted.

For more information:

Gallus, S.(2007), New sweeteners study shows no link with cancer, Annals of Oncology.

Please refer to the following credible bodies from around the world below

Scientific Committee on Food of the European Commission

The food safety advisory body in Europe, the Scientific Committee on Food (SCF) of the European Commission, reconfirmed aspartame's clean bill of health following a comprehensive review of the sweetener's safety. The SCF was a body of independent scientific experts which advised the European Commission on matters of food safety before the European Food Safety Authority (EFSA) was set up; the SCF's aspartame report was issued on December 10, 2002.

Aspartame was first approved for use in the UK in 1983 following a review by the Committee on Toxicity (COT), a group of independent experts who advise the Government on the safety of food ingredients. The COT has fully reviewed aspartame after studying all the available scientific information and found it to be safe for consumption. Up-to-date bulletins regarding this information can be found here.

The French Food Safety Agency (AFSSA) in 2002 completed a two year study by the French Expert Committee on Flavourings, Food Additives and Processing Aids and has confirmed the safety of aspartame once again. The English translation of its report and opinion on the safety of aspartame is now available.

The United States Food & Drug Administration (FDA) approved aspartame for use in dry products in 1981 and for use in sparkling beverages in 1983. The FDA affirmed the safety of aspartame no fewer than twenty-six times leading up to the agency's approval of aspartame as a general purpose sweetener in 1996.

Health Canada states, "...Before consideration was given to permitting aspartame for use in foods in Canada, officials of Health Canada evaluated an extensive array of toxicological tests in laboratory animals and, since its listing for use, they have examined the results of a number of clinical studies in humans. There is no evidence to suggest that the consumption of foods containing this sweetener, according to the provisions of the Food and Drug Regulations and as part of a well-balanced diet, would pose a health hazard to consumers."

This press release and clarification report regarding a scientific forum about aspartame held by the Health Surveillance Agency, an organization of the Brazilian Health Ministry, confirms that aspartame is not harmful and can be an excellent tool in managing diabetes and weight-loss programs.

A survey was undertaken in September 2003 which looked in detail at intake levels of aspartame among average and high consumers. The survey found that, among average consumers of aspartame, the intakes were low and that even among high consumers (those who regularly consume large amounts of drinks and other foods containing aspartame), intake was below 25% of the ADI. In summary, FSANZ concluded that aspartame is a safe food additive.

After investigating consumer inquiries, the CDC concludes that, although certain individuals may be unusually sensitive to aspartame, there is no evidence of any serious, widespread, adverse health consequences attendant upon its use. An agency of the Department of Health and Human Services, CDC's mission is to promote health and quality of life by preventing and controlling disease, injury, and disability.

The Alzheimer's Association is the largest US voluntary health organization supporting Alzheimer's research and care. The site states, "Several studies have been conducted on aspartame's effect on cognitive function in both animals and humans. These studies found no scientific evidence of a link between aspartame and memory loss."

The American Cancer Society (ACS) is committed to fighting cancer through balanced programs of research, education, patient service, advocacy, and rehabilitation. The ACS's Web site clearly states that aspartame does not cause cancer. In fact, aspartame (due to the nature in which it is metabolized) never reaches the organs of the body.

ACSH reminds consumers that aspartame is safe and offers further general information on low calorie sweeteners. ACSH is a consumer education consortium concerned with helping consumers distinguish between real and hypothetical health risks.

American Diabetes Association, the nation's leading non-profit health organization providing diabetes research, information and advocacy, states that there is no credible scientific evidence linking aspartame to any health-related problems for people with diabetes.

ADA concludes aspartame is safe and has issued a position statement approving non-nutritive sweeteners including aspartame. ADA is the professional organization that establishes standards of quality for practice for

nearly 70,000 dietetic professionals, most of whom are registered dieticians.

The American Heart Association is dedicated to providing education and information on fighting heart disease and stroke. The organization has found, through extensive investigation, that aspartame has not caused any serious side effects.

The Asthma and Allergy Foundation of America is dedicated to helping those with asthma and allergies improve their quality of life through education, advocacy and research. This site notes that alleged reactions to aspartame have not been verified.

The Canadian Diabetes Association confirmed the safety of aspartame as part if its "Canadian Diabetes Association National Nutrition Committee Technical Review: Non-nutritive Intense Sweeteners in Diabetes Management," which was published in the Canadian Journal of Diabetes. The review notes, "At this time, there is no scientific evidence to support the negative health effects that have been ascribed to aspartame."

Diabetes U.K. is the largest advocacy organisation for people living with diabetes in the United Kingdom. The organisation funds research, acts as a lobbying group and campaigns for the improvement of those living with diabetes. Diabetes U.K. provides position statements on the safety and helpfulness of aspartame and other low-calorie sweeteners, stating there is no evidence to support any of the questions that have been raised in relation to the safety of aspartame.

The Lupus Foundation of America is a nationwide volunteer organization serving the lupus community, including patients, their families, physicians, researchers, and the general public. The site notes in this question asking whether there was "any truth to the claims being circulated on the Internet that lupus is caused by the artificial sweetener, aspartame?" that there is no credible scientific evidence to support a link between aspartame and lupus.

Scientists at the Massachusetts Institute of Technology's Clinical Research Center conducted a study which concluded that aspartame is safe for the general population. Findings are noted here in this section entitled "Study reaffirms safety of aspartame." MIT is known for its Nobel prize-winning staff and excellence in science and math.